Evidence map›Paper›PMID 38812776›Full record

ArticleFrontiers in oncology2024

Phase II trial of vaccination with autologous, irradiated melanoma cells engineered by adenoviral mediated gene transfer to secrete granulocyte-macrophage colony stimulating factor in patients with stage III and IV melanoma.

Tamara A Sussman, Mariano Severgnini, Anita Giobbie-Hurder, Philip Friedlander, Scott J Swanson, Michael Jaklitsch, Thomas Clancy, Laura A Goguen, David Lautz, Richard Swanson and 4 more

Abstract read
In one paragraph

Article in Frontiers in oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Tamara A SussmanDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
Mariano SevergniniDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
Anita Giobbie-HurderDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
Philip FriedlanderDepartment of Hematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Scott J SwansonDepartment of Surgery, Brigham and Women's Hospital, Boston, MA, United States.
Michael JaklitschDepartment of Surgery, Brigham and Women's Hospital, Boston, MA, United States.
Thomas ClancyDepartment of Surgery, Brigham and Women's Hospital, Boston, MA, United States.
Laura A GoguenDivision of Otolaryngology, Brigham and Women's Hospital, Boston, MA, United States.
David LautzDepartment of Surgery, Emerson Hospital, Concord, MA, United States.
Richard SwansonDepartment of Surgery, UMass Chan Medical School, Worcester, MA, United States.
Heather DaleyConnell and O'Reilly Families Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, MA, United States.
Jerome RitzDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
Glenn DranoffDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
F Stephen HodiDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In the era of immune checkpoint blockade, the role of cancer vaccines in immune priming has provided additional potential for therapeutic improvements. Prior studies have demonstrated delayed type hypersensitivity and anti-tumor immunity with vaccines engineered to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF). The safety, efficacy and anti-tumor immunity of GM-CSF secreting vaccine in patients with previously treated stage III or IV melanoma needs further investigation. Methods: In this phase II trial, excised lymph node metastases were processed to single cells, transduced with an adenoviral vector encoding GM-CSF, irradiated, and cryopreserved. Individual vaccines were composed of 1x10 Results: GM-CSF vaccine was successfully developed and administered in all 61 patients. Toxicities were restricted to grade 1-2 local skin reactions. The median OS for stage III patients (n = 20) was 71.1 (95% CI, 43.7 to NR) months and 14.9 (95%CI, 12.1 to 39.7) months for stage IV patients. The median PFS in stage III patients was 50.7 (95%CI, 36.3 to NR) months and 4.1 (95% CI, 3.0-6.3) months in stage IV patients. In the overall population, the disease control rate was 39.3% (95%CI, 27.1 to 52.7%). In stage III patients, higher pre-treatment plasma cytokine levels of MMP-1, TRAIL, CXCL-11, CXCL-13 were associated with improved PFS (p<0.05 for all). An increase in post-vaccination levels of IL-15 and TRAIL for stage III patients was associated with improved PFS (p=0.03 for both). Similarly, an increase in post-vaccination IL-16 level for stage IV patients was associated with improved PFS (p=0.02) and clinical benefit. Conclusions: Vaccination with autologous melanoma cells secreting GM-CSF augments antitumor immunity in stage III and IV patients with melanoma, is safe, and demonstrates disease control. Luminex data suggests that changes in inflammatory cytokines and immune cell infiltration promote tumor antigen presentation and subsequent tumor cell destruction. Additional investigation to administer this vaccine in combination with immune checkpoint inhibitors is needed.

Indexed as

advanced diseaseGM-CSFmelanomastage IIIStage IVvaccine

Identifiers

PMID38812776
PMCPMC11133610

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.